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WORLD INTELLECTUAL PROPERTY ORGANIZATION
International Bureau

per

INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCI)

(51) International Patent Classification 5 :

G01N 21/01, 21/75

(11) International Publication Number: WO 92/15861

(43) International Publication Date: 17 September 1992 (17.09.92)

'4 .

(21) International Application Number:

PCT/US92/01734

27 February 1992 (27.02.92)

(22) International Filing Date:

(30) Priority data:

661,850 27 February 1991 (27.02.91) US

(71) Applicant: BOEHRINGER MANNHEIM CORPORA-

TION [US/US]; 91 15 Hague Road, P.O. Box 50528, In-
dianapolis, IN 46250-0528 (US).

(72) Inventors: GRANT, Michael, E. ; 1500 Dover Highway,

P.O. Box 1929, Sand Point, ID 83864 (US). GRAY, Rus-
sell, T. ; 1069 East Clifford Road, Brownsburg, IN 461 12
(US). GREGORY, Mark, A. ; 13171 Foster Court, Car-
mel, IN 46250 (US). KENNEDY, Daniel, L. ; 7756 Cas-
tle Ridge Court, Indianapolis, IN 46250 (US). PERIN,
Dino ; R.R. 2, SM 20, New Palestine, IN 46163 (US).
RIEDEL, Richard ; 10012 Holaday Drive, Carniel, IN
46032 (US). SCOPATZ, Stephen, D. ; 734 East 73rd
Street, Indianapolis, IN 46240 (US). STORVICK, David,
E. ; 61 1 Shady Creek Drive, Greenwood, IN 46142 (US).

(74) Agents: CONARD, Richard, D. et ah; Barnes & Thorn-
burg, 1313 Merchants Bank Building, 11 South Meridi-
an Street, Indianapolis, IN 46204 (US).

(81) Designated States: AT (European patent), BE (European
patent), CH (European patent), DE (European patent),
DK (European patent), ES (European patent), FR (Eu-
ropean patent), GB (European patent), GR (European
patent), IT (European patent), JP, LU (European pa-
tent), MC (European patent), NL (European patent), SE
(European patent).

Published

With international search report.

(54) Title: TEST STRIP HOLDING AND READING METER
(57) Abstract

A device (10) for accepting a strip (106) supporting a chemistry
which reacts with a medically significant component of a body fluid to
indicate the concentration of the component in the body fluid. The de-
vice (10) comprises a pathway (166) along which radiation is guided
from a radiation source (264) to the strip (106) when the strip (106) is
inserted into the device (10) and along which remission is guided from
the strip (106) to a radiation detector (266) when the stnj> (106) is in-
serted into the device (10X and a housing (120) for providing a first
remission. The housing (120) receives radiation from the radiation
source (264) and produces the first remission which is guided along the
pathway (166) to the radiation detector (266) when no strip (106) is in
the device (10). The housing (120) is separated from the radiation
source (264) by the strip (106) when the strip (106) is inserted into the
device (10). The first remission and the strip's (106) remission indicate
the absence and the presence, respectively, of the strip (106) in the de-
vice (10).

FOR TUB PURPOSES OF INFORMATION ONLY

Codes used to identify States party to the PCI on the front pages of pamphlets publishing international
applications under the PCT.

Austria

Hnland

Ml.

Mafi

Australia .

France
Gabon

Mongolia

Barbados

Mauritania

Belgium

United Kingdom

Malawi

Burkina haso

Guinea

Netherlands

Bulgaria

Greece

Norway

Benin

Hungary

Poland

BnwH

Ireland

Romania

Canada

Italy

Russian Federation

Centra) ATncan Republic

Japan

Sudan

Congo

Democratic Peopled Republic

Sweden

Stvit/ci land

of Korea

Senegal

Cote dt voire

Republic of Korea

Soviet Union

Cameroon

Ijccbtcnstcin

Chad

Occhushwakij

Sri Lanka

Togo

Germany

Luxembourg

United States of America

IXmmjrk

Monaco

Spain

Madagascar

WO 92/15861

PCT/US92/01734

TEST SHOP HOLDING AND READING METER

This invention relates to apparatus and methods
5 for reading the concentration of a medically significant
component of a biological fluid from a test strip.

TntittPtriai applicability

The invention is disclosed in the context of an
10 apparatus and a method for reading the concentration of
glucose in blood reacted on a test strip with a chemistry
with which the strip has previously been treated.

p^cKgyounfl Art:

15 The difficulty many people have with preparing

test strips treated with chemistries with bodily fluids
such as blood and urine is known. Many users of such
strips have .poor eyesight owing to diabetes, to age, and
to other causes as well. Many users have reduced

20 dexterity or strength in their hands owing to age and to
other causes. Frequently these causes are the reasons
why these users are testing their bodily fluids for , for
example, glucose concentration to begin with.

The problems with such strips only begin with

25 dosing the strips with the bodily fluid or fluids to be
analyzed. The chemistries are reactants with the
medically significant component (s) of the fluids. These
reactants react with the medically significant
component (s) resulting typically in some colorimetric

30 indication of the concentration of the medically

significant component of the fluid. However, these
reactions continue, typically for extended times, until
all of the reactants have reacted. Consequently, it is
generally necessary to time the reaction of the medically

35 significant component with the strip chemistry so that a

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colorlmetric comparison of the reacted strip chemistry to
a standard on a color chart can be made at some
established time after the reaction is initiated by
depositing the fluid on the strip. Otherwise, if the
5 reaction is not permitted to proceed long enough, or is
permitted to proceed too long, the color corresponding to
the extent of the reaction will not match the correct
standard on the chart*

In addition to potential problems with how long
10 the chemistry on the strip and the medically significant
component of the body fluid are permitted to react, there
are problems with many of such chemistry systems with how
much of the body fluid is applied to the strip, since
incorrect amounts of the reactants may affect the
15 validity of the test as adversely as errors in the timing
of the reaction* Either way, a false reading, sometimes
with dire consequences, will result.

The present invention makes use of an endpoint.
chemistry system of the type described in U.S. Patent
20 4,929,545. The disclosure of U.S. Patent 4,929,545 is
incorporated herein by reference. The advantages of an
endpoint chemistry are clear. For the user who
frequently has poor eyesight and/or manual dexterity ,
there is no need to be concerned about how long the
25 reaction has proceeded. The reaction reaches an endpoint
in relatively short order after which there is no
significant shift in the color of the reaction products
on the strip. In addition, the architecture of the strip
described in U. S.S.N. 07/661,788, filed February 27,
30 1991, IMPROVED TEST STRIP, naming as inventors McCroskey,
Freitag, Smith, Dean, Secrest and Bouse, and assigned to
Boehringer Mannheim Corporation, is such that the proper
dose of the body fluid, the biologically significant
component of which is to be reacted with the chemistry on
35 the strip, will always be available for the reaction.

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Any excess is wicked away from the reaction site by the
strip architecture. Thus, all the user need do is be
sure enough of the bodily fluid is present at the
reaction site on the strip to react with the chemistry
5 with which the strip is treated. The disclosure of

U.S. S.N. 07/661,788 is incorporated herein by reference*

Pigstpswe Qt the invention .

According to one aspect of the invention, a

10 device accepts a strip supporting a chemistry, the

remission of which changes as the chemistry reacts with a
medically significant component of a body fluid to
indicate the concentration of the component in the body
fluid. The strip has opposed major surfaces. The device

15 comprises a pathway along which radiation is guided from
a radiation source to the chemistry and along which
remission is guided from the chemistry to a radiation
detector when the strip is properly inserted into the
device. A tile provides a standard remission. Means are

20 provided for movably supporting the tile to permit it to
move from a position in which it receives radiation from
the radiation source and produces the standard remission
which is guided along the pathway to the radiation
detector when no strip is inserted into the device to a

25 position separated from the radiation source by the strip
when the strip is inserted into the device. The means
for movably supporting the tile comprises a strip carrier
including a carrier body having a surface facing the
tile, and a lift for movable engagement by the carrier.

30 One of the carrier and lift provides a pair of elongated
slots the long dimensions of which extend generally
transversely to the directions of motion of the strip
into and from the device and generally transversely to
the major surfaces of the strip when the strip is

35 inserted into the device. The other of the carrier and

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lift has a pair of oppositely extending trunnions for
engaging the slots. The lift further includes incline
means for engagement by the strip as the strip is
inserted into the device to move the lift away from the
5 carrier as permitted by the engagement of the trunnions
in the slots and permit insertion of the strip between
the carrier and lift. The incline means are provided at
an entry end of the carrier and lift. Means are provided
for yieldably urging the lift toward the facing surface
10 of the carrier so that the lift lies against the facing
surface of the carrier when no strip is inserted into the
device.

Illustratively according to this aspect of the
invention, one of the lift and tile further includes a
15 pair of opposed, aligned holes extending generally

transversely to the directions of motion of the strip
into and from the device. The axes of the holes extend
generally parallel to the major surfaces of the strip
when the strip is inserted into the device. The other of

20 the lift and tile includes a pair of oppositely extending
second trunnions for engaging the holes to mount the tile
pivotally from the lift.

Further illustratively according to this aspect
of the invention, the facing surf ace and the tile are so

25 shaped that the tile surface is maintained at a distance
from the facing surface of the darrier when no strip is
inserted into the device and at a distance from the strip
when a strip is inserted into the device.

Additionally illustratively according to this

30 aspect of the invention, the device further comprises a
housing for positioning the assembly including the strip
carrier, the lift and the tile. The housing includes a
second surface remote from, and generally parallel to,
the facing surface when the assembly including the

35 carrier, the lift and the tile is positioned in the

WO 92/15861 PCT/US92/01734

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housing. The lift and tile lie between the facing
surface and second surface. The means for yieldably
urging the lift toward the facing surface comprises a
compression spring which bears against the second surface
5 and at least one of the lift and the tile.

Illustratively according to this aspect of the
invention, the housing further comprises means for.
supporting the radiation source. The pathway along which
radiation is guided from the source to the chemistry when

10 the strip is properly inserted into the device includes a
first slot formed in the facing surface opposite the tile
when no strip is inserted into the device and opposite
the chemistry when a strip is properly inserted into the
device. The first slot is located adjacent the means for

15 supporting the radiation source for directing radiation
therefrom onto the tile when no strip is inserted into
the device and onto the chemistry when a strip is
properly inserted into the device.

Further illustratively according to this aspect

20 of the invention, the pathway along which remission is
guided from the chemistry to the radiation detector when
a strip is properly inserted into the device also
includes the first slot.

Additionally illustratively according to this

25 aspect of the invention/ the housing includes a third
surface which lies adjacent the facing surface when the
assembly including the carrier, the lift and the tile is
inserted into the housing. The third surface lies
adjacent the carrier body and extends generally parallel

30 to the facing surface. The pathway along which remission
is guided from the chemistry to the detector when a strip
is properly inserted into the device includes a second
slot formed in the third surface adjacent the first slot.

Additionally illustratively according to this
35 aspect of the invention, the housing includes a fourth

WO 92/15861 PCT/US92/01734

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surface lying at a small/ nonzero angle to the third
surface. The pathway along which radiation is guided
from the source to the chemistry when the strip is
properly inserted into the device includes a third slot
5 formed in the fourth surface. Illustratively the fourth
surface lies between the means for supporting the
radiation source and the chemistry when the strip is
properly inserted into the device. Illustratively the
third slot lies between the source and the chemistry when

10 the strij> is properly inserted into the device. Further
illustratively the first slot lies between the third slot
and the chemistry when the strip is properly inserted
into the device. Additionally illustratively the first
slot lies between the chemistry and the detector when the

15 strip is properly inserted into the device.

Illustratively the second slot lies between the first
slot and the detector.

Further illustratively according to this aspect
of the invention , the second surface lies adjacent the

20 facing surface when the assembly including the carrier,
lift and tile is inserted into the housing. The second
surface lies adjacent the carrier body and extends
generally parallel to the facing surface. Radiation is
guided along a second pathway from a second radiation

25 source to the strip when the strip is inserted into the
device. Remission is guided from the strip to a second
radiation detector along the second pathway when the
strip is inserted into the device.

Additionally illustratively the device is
30 incorporated into an instrument for determining the

concentration of a medically significant component of a
body fluid and for indicating the determined
concentration of the medically significant component to a
user of the instrument. The instrument comprises an
35 instrument case for the instrument's components including

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the device. One of the instrument's components comprises
a printed circuit board. The housing, the
first-mentioned and second radiation sources , and the
first-mentioned and second radiation detectors are all
5 mounted on the printed circuit board.

Further illustratively according to this aspect
of the invention, the housing includes a third surface
lying adjacent, and extending generally parallel to, the
carrier body. One of the third surface and carrier body

10 is provided with a locating protrusion and the other of
the third surface and carrier body is provided with a
recess for receiving the protrusion to locate the
carrier, lift and tile correctly within the housing when
the holder with the carrier, lift and tile assembled and

15 supported thereon is assembled to the case by sliding

insertion of the carrier, lift and tile assembly into the
housing. Illustratively the protrusion and the relief
are generally f rustoconical . Illustratively the
protrusion is provided on the third surface.

20 Further illustratively according to this aspect

of the invention, the case includes a removable case
portion having an exterior surface and an interior
surface. The exterior surface lies on the outside of the
case when the case portion is in its use orientation on

25 the instrument, and the interior surface lies on the
inside of the case when the case portion is in its use
orientation on the instrument. One of the interior
surface and the strip carrier is provided with a pair of
generally pawl-shaped members which extend away from the

30 interior surf ace and define between them a slot which
opens into a somewhat triangular region near their ends
remote from the interior surface, then closes back to its
slot configuration. The other of the interior surface
and the strip carrier includes a web portion having

35 opposite sides from each of which project two, generally

WO 92/15861

PCT/US92/01734

parallel guide ribs and, between the guide ribs of each
pair, a projection for engaging the triangular region
defined between the remote ends of the pawl-shaped
members when the web portion is inserted into the slot.
5 According to another aspect of the invention, a

device accepts a strip supporting a chemistry which
reacts with a medically significant component of a body
fluid to indicate the concentration of the component in
the body fluid. The device comprises a pathway along

10 which radiation is guided from a radiation source to the
strip when the strip is inserted into the device and
along which remission is guided from the strip to a
radiation detector when the strip is inserted into the
device, and a housing for providing a first remission.

15 The housing receives radiation from the radiation source
and produces the first remission which is; guided along
the pathway to the radiation detector when no strip is
inserted into the device. The housing is separated from
the radiation source by the strip when the strip is

20 inserted into the device. The first remission and the
strip "s remission indicate the absence and the presence,
respectively, of the strip in the device.

Illustratively according to this aspect of the
invention, the strip has opposed major surfaces, the

25 strip's remission being the remission of a first of the
major surfaces, and the second of said major surfaces
characterized by a second strip remission different from
the first strip remission. The radiation detector
produces a first output in response to detection of the

30 first strip remission and a second and different output
in response to the second strip remission.

Further illustratively according to this aspect
of the invention, the device further comprises a second
radiation source, a second radiation detector, and a

35 second pathway along which radiation is guided from the

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second source to the chemistry when the strip is properly
inserted into the device and along which remission is
guided from the strip to the second radiation detector
when the strip is properly inserted into the device. The
5 second radiation detector produces different outputs
based upon differences in remission of the chemistry
corresponding to different concentrations of the
medically significant component in the body fluid.

10 Brief Description of the Drawings

The invention may best be understood by
referring to the following detailed description and
accompanying drawings which illustrate the invention. In
the drawings:

15 Figs. 1-8 illustrate exploded perspective

views, from various different angles, of various
components of an instrument constructed according to the
present invention;

Fig. 9 illustrates a partly block and partly
20 schematic circuit diagram of the electric circuit of the
instrument illustrated in Figs. 1-8;

Fig. 10 illustrates a type of flow diagram
useful in understanding the operation of the instrument
illustrated in Figs. 1-8;
25 Fig. 11 illustrates a % remission versus time

curve useful in understanding the operation of the
software of the instrument of Figs. 1-9; and

Fig. 12 illustrates another % remission versus
time curve useful in understanding the operation of the
30 software of the instrument of Figs. 1-9.

Mode For Carrying Out the I nvention

Referring now to Figs. 1 and 8, an instrument
10 according to the invention includes a case 12 having a
35 front portion 14, a rear portion 16, a key housing

WO 92/15861

PCT/US92/01734

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portion 18 and a strip carrier holder portion 20. A
printed circuit board 22 , the contents of which will be
considered in more detail in the discussion of Fig- 9, is
sandwiched generally between the front and rear portions
5 14, 16, respectively* Front portion 14 includes a relief
24 of generally trapezoidal configuration at the center
of which is a generally circular opening 26. A generally
right circular cylindrical stem 28 extends downwardly
from the underside of front portion 14 beneath opening

10 26. This stem 28 slidably receives a stem 30 provided on
the back of an ON/OFF button 32 of the same shape as
relief 24. The lower end of stem 30 is split axially and
somewhat frustoconical in configuration so that button 32
is captured in relief 24 when stem 30 is pushed into

15 opening 26 until the split, frustoconical end 36 of stem
30 clears the bottom end 38 of stem 28. The portion of
stem 30 above end 36 is somewhat longer than stem 28 so
that some movement of button 32 vertically in relief 24.
is possible •

20 Front casing portion 14 also includes a wall 40

inside of , and parallel with, a region 42 of an end wall
therebf. Wall 40 includes a vertically extending groove
44 open at its bottom 46 and with a semicircular top 48.
A memory button 50 has ribs 52 on its back wall spaced

25 a£>art slightly less than the width of groove 44. Button
50 excluding ribs 52 is slightly thicker than the space
between wall 40 and region 42. The flexible resin
construction of front portion 14 and a circular opening
54 of slightly larger diameter than button 50 in region

30 42 permits the wall 40 to flex away from region 42 as

button 50 is forced into the space between them and snaps
into place protruding through opening 54^ A flange 56 on
button 50 keeps it from going all the way through opening
54 and falling from front portion 14.

35 The front and rear portions 14, 16 include

WO 92/15861

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-Ir-
respective, cooperating, somewhat arcuate cutouts 60, 62
(Figs. 1, 6 and 8), for key housing portion 18. Key
housing portion 18 is designed to receive an
electronically readable information carrier, or key, 64
5 (Fig. 2) of the type described in U.S. Patent 5,053,199.
The disclosure of U.S. Patent 5,053,199 is incorporated
herein by reference. Front and rear portions 14, 16 also
include cooperating cutouts 68, 70 (Figs. 1, 6 and 8) for
receiving the strip carrier holder portion 20. Front

10 portion 14 also includes a window 74 (Figs. 1 and 8)

around which a liquid crystal display 76-supporting bezel
78 (Figs. 3 and 7) fits on the inside of front portion
14. Bezel 78 mounts the LCD 76 so as to be visible
through window 74 and provides the necessary electrical

15 connections 79 to LCD 76.,

The back portion 16 of the case 12 also
includes means for mounting a piezoelectric beeper
transducer 80 (Fig. 6) and for providing^ electrical
contact .81 thereto and a battery housing cutout 82 having

20 a pivotal ly mounted door 84 for convenient insertion and
removal of a six-volt battery 86.

The lips 88, 90 of front and back portions 14,
16, respectively, are complementarity configured to snap
together. As further insurance against th&ir

25 inadvertently coming apart, a self tapping screw 92 (Fig.
1) through back portion 16 and into a stem 94 molded on
the inside of front portion 14 holds portions 14, 16
together. Screw 92 extends through a hole 96 provided
therefor in printed circuit board 22, which, along with

30 the configurations of the interiors of front and back
portions 14, 16, holds board 22 in place.

The strip carrier holder portion 20 includes an
outer case portion 100 provided with grooves 102 (Fig. 4)
on its top and bottom surfaces to aid in gripping it and

35 snapping it into and out of engagement with the front 14

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and back 16 case portions. Case portion 100 is provided
with an opening 104 for inserting chemistry strips 106,
the remissions of which are to be read, into the
instrument 10. The margins 108 of opening 104 are
5 somewhat funnel-shaped to assist in insertion of the^
strips 106 into the instrument 10 in the correct
orientation. A pair of somewhat pawl-shaped members 110
extend rearwardly of case portion 100 beneath opening
104. Members 110 define between them a slot 112 which

10 opens into a somewhat equilateral triangular region 114
near their remote ends 116, then closes back to its slot
configuration, and then opens into a somewhat funnel
shape 118 adjacent the remote ends 116 of members 110. A
strip carrier body 120 includes a lower web portion 122

15 along each of the opposite sides of which extend two

guide ribs 124. Web portion 122 is only slightly thinner
than slot 112 is for most of its length. Guide ribs 124
are spaced apart only slightly further than the vertical
thickness of each of members 110. These dimensions

20 permit strip carrier body 120 to be slid into the slot
112 defined between members 110. A triangular horizontal
cross section projection 126 spaced an appropriate
distance along web portion 122 on each side thereof
between guide ribs 124 cooperates with regibn 114 on case

25 portion 100 to lock strip carrier body 120 between

members lio.

Near its end remote from ca&e portion 100,
strip carrier body 120 includes a pair of horizontally
projecting ears 130, each of which is provided with an

30 elongated slot 132. Slots 132 extend generally

transversely to the directions of motion of strips 106 as
the strips are inserted into opening 104 and into the
strip carrier holder 20 and removed therefrom. A li ft
134 includes a pair of vertically, oppositely extending

35 trunnions 136 which engage in respective slots 132 to

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permit lift 134 to move away from strip carrier body 120
as a strip 106 to be read is inserted therebetween. Lift
134, in turn, includes a pair or horizontally extending
ears 138 at its forward end opposite the end at which
5 trunnions 136 are provided. Each ear 138 is provided
with a vertically extending circular cross section hole
140. A high reflectance (remission) white tile 142 is
provided with a pair of trunnions 144 by which it is
pivotally attached, by insertion of trunnions 144 into

10 respective holes 140, to lift 134. Directly across from
the point 146 at which white tile 142 projects through an
opening 150 provided therefor in lift 134, strip carrier
body 120 is provided with a slot 152. Strip carrier body
120 is also provided with another slot 154 between slot

15 152 and case portion 100, and with a frustoconical relief
156 (illustrated only in Fig. 1) on the side thereof
opposite the side to which lift 134. is attached.

An optics assembly 160 (Figs. l r 3 and 5)
mounted on the printed circuit board 22 cooperates with

20 the strip carrier holder portion 20. The cooperation of
these two components negates any possible misalignment
errors between the optics and the strips 106. This
cooperation is aided by the designs and tolerances of
some of the molded plastics parts from which the strip

25 carrier holder portion 20 and optics assembly 160 are

largely constructed. These designs and tolerances permit
the components of the strip carrier holder portion 20 and
optics assembly 160 which must be properly, aligned fbr
accurate reading of the reacted strips 1 106s 1 remissions

30 to align properly when the strip carrier holder portion
20 is assembled into the instrument case 12.

Optics assembly 160 includes an optics housing
162. Housing 162 houses a leaf spring 168 and, across
from spring 168, a wall 170 against which the spring 168

35 forces the strip carrier body 120 to position it and its

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related components 134 , 142 and a strip 106 carried
thereby properly relative to the instrument 10's optics.
A frustoconical projection (not illustrated) projecting
toward spring 168 from wall 170 adjacent the inner end
5 171 of housing 162 engages relief 156 on strip carrier
body 120 when strip carrier body 120 is correctly
positioned in optics housing 162, A pair 174, 176 (Fig.
3) of transparent plastic prisms, molded as a single
piece 177, are mounted on printed circuit board 22 in

10 separate internal regions 178, 180, respectively, (Fig.
5) of housing 162. A light emitting diode 182 is mounted
on board 22 and fitted into an LED adapter 184 which, in
turn, is fitted into an LED socket 186 provided on
housing 162. LED 182 is the initiation, or "upstream"

15 end, of a glucose measurement channel 164.

Wall 170 is provided with a vertical slit
opening 190 opposite the opening of socket 186 into
housing 162. In the assembled optics assembly 160, this
slit opening 190 is directly adjacent prism 174, the

20 smaller of the two prisms provided by piece 177. In

order to avoid receiving the direct reflected light from
the reacted test chemistry on a strip 106, prism 174 is
oriented ait an angle to the surface of the strip 106
other than the angle of incidence of light from LED 182

25 onto r or the angle of reflection of light from LED 182
f±6n, strip 106. Illustratively, prisiii 174 is oriented
at an angle of about 77* to the surface of strip 106.
This increases the likelihood that light received by
prism 174 is not direct reflected light, but rather

30 ambient remission light, from the reacted chemistry on
strip 106. This diffuse light is a better gauge than
direct reflected light of the end point of the reaction
between the glucose in blood applied to strip 106 and the
chemistry with which strip 106 is treated. Thus, this

35 ambient remission light is a better gauge of the

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concentration of the glucose content of the blood.

Prism 176 is oriented directly adjacent a slit
opening 191 through wall 170 in the assembled optics
assembly 160. The problem of obtaining a diffuse or
5 remission light component of the light reflected from
strip 106 is not so great with the light entering prism
176 as it is with the light entering prism 174 because
the light entering prism 176 is used only to determine
whether there is a strip in strip carrier body 120, and,

10 if so, whether the strip is properly oriented with its

chemistry immediately opposite opening 190 and prism 174.
Since prism 176 is not in the chemistry reading channel
164, the remission reading from it is not so critical.

Both of prisms 174, 176 have curved faces

15 facing strip 106. These curved faces function as lenses
to focus the light remissions entering the prisms on the
devices which detect these remissions. The lenses
incorporated into prisms 174, 176, in. other words, have
focal lengths equal to the distances from the lenses to

20 their respective regions of interest on the strip 106 and
also equal to the distances from the lenses to their
respective detector devices.

Turning now to Fig. 9, the operation of
instrument 10 is controlled by a microcomputer (mc) 200

25 such as the NEC type MPD75P308 pc. All subsequent

references herein to pin and terminal numbers and names
will be to the pin and terminal numbers and names of the
specific integrated circuits and other devices identified
herein as exemplary. It is to be understood, however,

30 that other integrated circuits may exist which are
equally suited to provide the functions required by
instrument 10. The clock for pc 200 is a 4.19 MHz
crystal 202 which is coupled across terminals X1-X2
thereof. The terminals of crystal 202 are also coupled

35 through respective 33pF capacitors to ground. The V DD

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supply for nc 200 is provided by a PNP transistor 204
such as a BC858C, the base of which is coupled through a
62W1 resistor 206 to terminal P4.1 of nc 200. The
collector of transistor 204 is coupled to positive
5 battery voltage (+6VDC) , hereinafter referred to as VBAT.
V DD appears at the emitter of transistor 204. The
collector of transistor 204 is coupled to its emitter by
the parallel combination of two 200 n resistors. The
cathode of a diode 208 is coupled to the emitter of

10 transistor 204. The anode of diode 208 is coupled to

ground. Diode 208 illustratively is a type 1N4 148 diode.

The RESET terminal of /ic 200 is coupled to the
collector of a transistor 210 and through a 10K n
resistor to V DD . The emitter of transistor 210 is

15 grounded. Its base is coupled through a 22KO resistor
212 to the junction of a .ljiF capacitor 214 and a 1MD
resistor 216. The other terminal of capacitor 214 is
coupled to VBAT. The other terminal of resistor 216 is
coupled to ground.

20 An electronic log book mode (ELB) connector 220

has three terminals. A first of these, 222 , is coupled
through a 10KO resistor to terminals P 3.0/LCDCL and
P 0.0/INT4 of pc 200. Terminal 222 is also coupled to
ground through the parallel combination of a 680pF

25 capacitor and a 220KH resistor. Terminal 224 is coupled
through a 10RB resistor to terminal P3.2 of fio 200, and
to ground through the parallel combination of a 680pF
capacitor and a 220KQ resistor. Terminal 226 is coupled
to ground.

30 The eight terminals 231-238 of the key housing

portion 18 are coupled, respectively, to: jic 200' s
terminal P7.3/KR7; /ic 200 , s terminal P7.2/KR6; 200' s
P7.0/KR4; pc 200' s terminal P6. 3 /KR3; ground; one
terminal of a 220KO resistor 240, the remaining terminal

35 of which is coupled to terminal 234; nothing (blank); and

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terminal 236.

A number of variables exist which affect the
reading of the reacted chemistry on a strip 106. For the
reading to be as free of errors as instrument 10 can make
5 it, these variables must be accounted for to the extent
possible by instrument 10 in the process of calculating
the end point remission of the reacted chemistry. One of
these variables is humidity, and it is taken into
consideration by a humidity sensor 242 of standard

10 configuration coupled between ground and an input

terminal P0.3/SI/SB1 of pc 200. Humidity sensor 242 is
also coupled through a IMfl resistor 244 and a .01/iF
capacitor 246 to ground. VBAT is supplied to the emitter
of a PNP transistor 248, illustratively a BC858C. The

15 collector of transistor 248 is coupled to key housing
portion 18 f s connectors 236 and 238 and to the junction
of resistor 244 and capacitor 246.

An internal EEPROM 250 has its CS, SK, DI and
DO terminals coupled, respectively, to the P7.1/KR5 ,

20 P7.2/KR6, P7.0/KR4 and P6.3/KR3 terminals of pc 200. The
and ORG terminals of internal EEPROM 250 are coupled
to the collector of transistor 248. The GND , terminal of
internal EEPROM 250 is coupled to ground.. Internal
EEPROM 250 illustratively is a Catalyst Semiconductor

25 type CAT93C46 integrated circuit, as is the integrated
circuit in code ROM key 64.

A series string of an 8.2Kn resistor 252, a
10Kn resistor 254, a 10KO resistpr 256, and a 10KO
resistor 258 is coupled between terminal P6.1/KR2 of

30 /XC200 and ground/ The junction of resistors 252, 254 is
coupled to terminals VLC0 and BIAS of pc 200. The
junction of resistors 254 and 256 is coupled to terminal
VLCl of pc 200. The junction of resistors 256 and 258 is
coupled to terminal VLC2 of pc 200.

35 Transducer 80 is coupled across terminal

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P2.3/BUZ of fic 200 and ground. A diode 260 is coupled
across transducer 80 with its anode coupled to ground and
its cathode coupled to terminal P2.3/BUZ. Another diode
262 has its anode coupled to terminal P2.3/BUZ and its
5 cathode coupled to V DD .

The COM0-COM2 and DS10-DS0 terminals,
respectively, of lie 200 are coupled to respective
terminals of the same names, pins 1-14, of LCD 76.

An infrared strip 106 sensor channel 166

10 includes an LED 264 and a light sensitive transistor
(LST) 266 separated by a partition in a common housing
(not shown) . The larger prism 176 is mounted on printed
circuit board 22 so that its bottom surface rests
directly on the top surface of the housing in which LED

15 264 and LST 266 sure housed. LED 264 and LST 266

illustratively are a Toshiba type TLP908 integrated
circuit. Light from LED 264 shines upward through the
bottom of the larger prism 176 and is reflected out
through the lens of prism 176 onto the strip 106. The

20 reflected light returns through the lens and is reflected
downward within the prism 176 and out the bottom thereof
where it is received by LST 266. The resultant
conductivity of LST 266 corresponds to a certain
percentage remission of the light from LED 264. That

25 percentage remission establishes whether a strip 106 is
present in strip carrier body 120 and, to an extent,
whether that strip 106, if present, is properly oriented.

The way the strip 106 and strip 106 orientation
are detected is as follows. Light returning in channel

30 166 to the base of LST 266 causes it to conduct. A

current mirror including NPN transistors 268 and 270 in
conventional current mirror configuration provides equal
currents through the collectors of these two transistors
in response to current flow in the emitter of LST 266. A

35 ,47pF capacitor 272 is coupled across the collector and

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emitter of transistor 270 and discharges at a rate
determined by the amount of light falling on the base of
LST 266 to which LST 266 is sensitive. This
configuration subtracts from the initial voltage across
5 capacitor 272 the integral of the light falling on the
base of LST 266. Current is supplied to LED 264 for a
predetermined, set period of time. The remission from
strip 106 to the base of LST 266 determines how deeply
discharged capacitor 272 becomes. Capacitor 272 is then
10 charged from a constant current source for a period of
time which is measured using the system clock, until
capacitor 272 has recharged to some reference voltage.
The length of the period that capacitor 272 takes to
recharge to reference voltage is a period of time, a
15 number of strokes of the system clock, and converts to a
digital value the percentage remission of channel 166.
This translates into the presence or absence of a strip
106 in the strip carrier body 120 and, to an extent, its
orientation in strip carrier body 120. The instrument
20 10, once it has established that a strip 16 is present in
the strip carrier body, next decides whether the strip
106 is properly oriented with its reagent pad in front of
Slot 190 and prism 174, or whether the strip 106 is
backward or upside down. Of course, the strip
25 architecture must be such that different ranges of

percentage remission readings are presented' for these
different strip 106 orientations, and this is so. See
U.S. S.N. 07/661,788. ^

To accomplish these objectives, the anode of
30 LED 264 is coupled to VBAT and its cathode is coupled to
the collector of a transistor 276, which illustratively
is a type BC848C NPN transistor. The emitter of
transistor 276 is coupled through an 820 feedback
resistor to ground. The base of transistor 276 is
35 provided with periodic LED 264 drive signals from

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terminal P5.1 of ftc 200. The base of transistor 276 is
also coupled through two diode-connected temperature
compensation transistors 280, 282 in series to ground.
Transistors 268, 270, 280, 282 illustratively are a type
5 MC3346D quad transistor integrated circuit. The emitter
of LST 266 is coupled to the collector and base of
current mirror transistor 268, and to the base of current
mirror transistor 270. The collector and base of
transistor 268 and the base of transistor 270 are also

10 coupled to terminal P5.0 of lie 200. The emitters of
transistors 268, 270 are grounded. The collector of
transistor 270, in addition to being coupled to capacitor
272, is coupled to the inverting (-) input terminal of a
difference amplifier 286, and to the collector of a PNP

15 transistor 288 such as a type BC858C transistor . The

output terminal of difference amplifier 286 is coupled to
the P3.1/SYNC terminal of fie 200. The emitter of
transistor 288 is coupled to terminal P5.3 of fic 200.
The base of transistor 288 is coupled to the output

20 terminal of a difference amplifier 290.

The inverting (-) and non-inverting (+) input
terminals of difference amplifier 290 are coupled through
a 20KD resistor and a 1500 resistor, respectively, to the
collector of LST 266. A 5. lKn resistor is coupled from

25 the base of transistor 276 to the collector of LST 266 as
well. The collector of LST 266 is coupled to the + input
terminal of a difference amplifier 294, the - input
terminal of which is coupled through a 150KI1 resistor to
terminal P6.0/KRO of pc 200. The output terminal of

30 difference amplifier 294 is coupled to terminal P3.3 of
Plc 200. The - input terminal of difference amplifier 294
is also coupled through a .01MF capacitor to ground.

Turning now to the mechanism and electronics by
which the remission of the reagent pad portion of strip

35 106 is read when a strip 106 is properly inserted into

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strip carrier body 120, LED 182 is the beginning of
channel 164. The anode of LED 182 is coupled to VBAT and
its cathode is coupled to the collector of an NPN
transistor 298. Transistor 298 illustratively is a type
5 BC848C transistor. The emitter of transistor 298 is

coupled through a 12 on feedback resistor to ground. The
base of transistor 298 is coupled to terminal P5.2 of pa
200 , and through a 20Kn resistor to the + input terminal
of difference amplifier 294. The remission of the

10 reagent pad of a strip 106 is supplied to a photosensor
300, such as a Siemens type TFA1001W integrated
photosensor. Photosensor 300 is mounted in closely
spaced relation to the bottom of the smaller prism 174 so
that remissions from the chemistry region of strip 106

15 that enter the lens surface of prism 174 are reflected

down through it and exit from its bottom into photosensor
300.

Power for photosensor 300 is provided through a
PNP transistor 302, which illustratively is a type BC858C

20 transistor. The emitter of transistor 302 is coupled to
VBAT. Its base is coupled through a 62KH resistor to
terminal P4.2 of jic 200. Its collector is coupled to
ground through a 22/iF tantalum capacitor 304. The
voltage VD1 across capacitor 304 is coupled across

25 terminals + VS and - VS of photosensor 300. A .OljiF

capacitor is also coupled across terminals + VS and - VS.
The VSTAB and FCOMP terminals of photosensor 300 are
joined through a lMfl resistor. The VSTAB terminal is
also coupled to the + input terminal of a difference

30 amplifier 308. The - input terminal of difference

amplifier 308 is coupled to its output terminal, making
it an inverting amplifier. The output terminal of
difference amplifier 308 is also coupled to the + input
terminal of difference amplifier 294. Difference

35 amplifiers 286, 290, 294 and 308 illustratively are a

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type LM324A quad difference amplifier integrated circuit.

Terminal P6.2/KR2 is coupled through a 220KO
resistor to the anode of a diode 310 which illustratively
is a type IN4148. The cathode of diode 310 is coupled to
5 the INHIBIT terminal of photosensor 300. The conductor
extending between the cathode of diode 310 and the
INHIBIT terminal of photosensor 300 is capacitively
coupled through a 680n resistor to ground and through a
360n resistor to the + input terminal of difference

10 amplifier 286. The + input terminal of difference

amplifier 286 is coupled through a 20011 resistor to the +
input terminal of difference amplifier 290. The OUTPUT
terminal of photosensor 300 is coupled to the - input
terminal of difference amplifier 286.

15 one terminal of ah ON/OFF switch 312 operated

by ON/OFF button 32 is coupled to ground. The other
terminal of ON/OFF switch 312 is coupled to the Pl.l/INTl
terminal of pc 200. The P1.2/INT2 terminal of no 200 is
coupled to one terminal 316 of a memory switch 314

20 operated by memory button 50. Terminal 316 of memory

switch 314 is coupled through a 220KO resistor to ground.
The other terminal of memory switch 314 is coupled
through a 220KQ resistor to the Pl.l/INTl terminal of
lie 200.

25 The symbols which can appear on LCD 76 include

numbers 00.0 through 99.9, the indications mg/dL
(milligrams per deciliter) , mmoi/L (millimoles per
liter) , mem (which stands f or memory) , a battery icon, an
icon of a blood droplet being deposited on a strip, the

30 word code, and an error icon, a box with an "X" through
it, each quadrant of the box being capable of being
separately energized.

Referring now to Fig. 10, the instrument 10 is
turned on by depressing ON/OFF button 32. Instrument 10

35 actuates prior to release of ON/OFF button 32.

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Immediately after the instrument 10 is turned on, it
performs a power-on system integrity test and a battery
voltage test. If the battery 86 voltage is below 4.5
volts, a battery low warning (battery icon on LCD 76) is
5 displayed. If the battery 86 voltage is below 4.2 volts,
the instrument 10 will not turn on. Following being
turned on, all segments of the display 76, including all
icons, are displayed for 2 seconds. If it is enabled,
the transducer 80 sounds for the first one/half second of

10 this 2 second display check.

After 2 seconds, all segments and icons
disappear and the ROM code number from key 64 and code
icon appear on LCD 76 for 2 seconds, then disappear.
During this time, the instrument 10 scales itself using

15 the remission of white tile 142. Scaling is followed by
the lighting of the strip icon, right arrow icon, and
flashing blood drop icon. This icon display prompts the
user to apply blood to the strip 106 and then to insert .
the dosed strip 106 into the opening 104 provided

20 therefor in instrument 10.

The user applies blood to the strip 106 and
allows it to soak into the strip mesh until it is fully
absorbed. Within two seconds of proper insertion of the
strip 106, the instrument 10 deletes the strip icon,

25 blood drop icon ^nd . right arrow icon from display 76, and
begins the timing period for the chemistry in the reagent
pad of strip 106 to react with the medically significant
component, glucose in this example, of the applied blood.
Within two seconds of insertion of the strip 106, the

30 display 76 sequentially displays (in clockwise rotation)
the quadrants on the error or "X" display at a rate of
one segment per half second. No timing need b0 displayed
on the instrument 10 f s LCD 76 because of the employment
of an endpoint chemistry on strips 106. When the strip

35 106»s reaction is determined by the instrument 10 to have

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reached an endpoint, the instrument 10 beeps once and
then displays a blood glucose value and the mg/dL icon.
The instrument 10 also displays the strip icon and left
arrow icon to prompt the- user to remove the reacted strip
5 106. The glucose result is stored in the newest (first)
memory location, pushing all previously stored glucose
readings down one location in memory.

After the strip 106 is removed, the instrument
10 again rescales itself from the white tile 142 to ready

10 itself for the next strip 106 reading. The instrument 10
then returns to the dosed strip insertion prompt.

The instrument 10 can verify that an unreacted
strip 106 is acceptable for use. It does this by reading
the unreacted strip 106 to make sure that its reagent pad

15 remission value is within the specified percent remission
limits stored in the code ROM key 64. Performance of
this check is at the user's discretion. The instrument
10 is capable of performing this check when the
instrument is prompting for a dosed strip or during a

20 memory recall display.

To perform this strip 106 integrity check, the
user removes an unreacted strip 106 from the vial
containing such strips and inserts the unreacted strip
106 into the instrument 10 's slot 104 with the reagent

25 pad facing the optics. Within two seconds after a strip
106 has been inserted, the instrument 10 detects the
presence of a strip 106 and begin its timing display.
During this display, the user must depress the memory
button 50 once. This causes the instrument 10 to perform

30 the strip 106 integrity check. After the memory button
50 has been pressed, the instrument 10 will read the
strip 106* s remission and compare the strip 106* s
remission against the programmed limits that have been
provided by the lot specific ROM key 64.

35 strip 106 integrity approvkl is signaled

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through the strip removal prompt and a single beep.
Strip 106 approval permits the user to proceed with a
test on a reacted strip 106 by prompting for a dosed
strip after the unreacted strip 106 is removed.
5 Strip integrity errors are signaled through the

display of the flashing error ("X") icon, flashing strip
icon and three beeps. The instrument 10 remains in this
display state until the bad strip 106 is removed. After
strip 106' s removal, the instrument 10 prompts for a

10 dosed strip.

Glucose test values are stored automatically
after every test using "first (oldest) in, first deleted"
and "last (newest) in, first recalled" protocols. Once
the memory has filled to its thirty reading capacity,

15 each new reading added causes the oldest reading to be
deleted from memory.

Memory recall mode is accessible from the dosed
strip prompt. Memory recall function is Initiated by
pushing the memory button 50 once. This displays the

20 first memory location (1) .

After one second, the display changes to
display the contents (a glucose reading) of the selected
memory location. The display reverts to the memory
location display (1 in this example) after 4 seconds. If

25 no button is pushed, the cycle of memory location and

memory location contents continues to repeat itself for 5
minutes before the instrument 10 turns itself off. The
memory display cycle can also be terminated by the
insertion of a test strip 106 into the instrument 10.

30 Recall of the remaining values from memory is

accomplished by pressing the memory button 50 over and
over again until all thirty stored values and their
memory locations have been displayed. Each time the
memory button 50 is depressed, the next memory location
35 is displayed. Memory locations and results cycle to

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location 1 once the user advances beyond the oldest
value. If fewer than 30 results are stored in memory,
the first location (location 1) is displayed following
the last result stored when the memory is advanced beyond
5 the last result. The memory icon is displayed at all
times during memory recall.

If at any point a strip 106 is inserted, the
instrument 10 reverts to the test/timing mode. Insertion
of a strip 106 (reacted or unreacted) automatically

10 causes the instrument 10 to revert to this mode and
resets memory to the first (newest) location.

The instrument 10 uses the code ROM key 64 as
follows: With the instrument 10 off, the user removes
the old ROM key 64 from the instrument 10 and discards

15 it. A new ROM key 64 is packaged in every supply of
strips 106. The user inserts the new ROM key 64
containing information pertinent to the new supply of
strips 106 into the key housing portion 18 on the
instrument lb prior to turning the instrument 10 on. When

20 the instrument 10 is turned on, the instrument 10 checks
the integrity of the data contained in ROM key 64 via a
checksum method. If the ROM key 64 data is found to be
questionable, then a code error is displayed. During the
performance of a test, prior to the calculation of a new

25 glucose result, the instrument 10 checks the ROM key 64
to see if it has been changed* If the ROM key 64 has
been changed since the instrument 10 was turned on, a
code error is displayed. The instrument 10 remains in
this display until it either times itself off (5

30 minutes) , or is turned off.

When test results exceed the upper limit
contained in the ROM key 64, then the message HI is
displayed in place of a numeric result. If the result
does not exceed the lower limit contained in the ROM key

35 64, LO appears Oh the display. The mg/dL icon is

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displayed in both cases.

Instrument 10 verifies the remission of its
white tile 142 and signifies a dirty tile 142 by
displaying CLE (for "clean" } on display 76. The
5 instrument 10 does not permit the user to begin a testing
procedure or memory recall from this display. The only
remedy for this error is to turn the instrument 10 off.
This error occurs if the, slope calculated from the
remission of the white tile 142 is not within instrument

10 10' s internal slope limits, typically +5% to -10% of its
target value. This error also occurs if the instrument
10 is turned on with a strip 106 inserted in it.

The instrument 10 shuts itself off
automatically 5 minutes after the last button push or

15 strip 106 insertion. Automatic shut off occurs

regardless of instrument 10 mode or the last button
pressed. Depressing ON/ OFF button 32 while the instrument
10 is on turns the instrument 10 off.

Transducer 80 provides an audible beep: when

20 the instrument 10 is tufiied on (0.5 second); when a strip
106 is inserted into opening 104 (0.25 second); whenever
an error message is displayed (three times for 0.1 second
each); at the end of a test to indicate that a result is
displayed or an unreacted strip 106 is usable (0.25

25 second); and, whenever either button 32 or button 50 is
depressed as a "key click" sound (two cycle duration) .
Transducer 80 actuation can be enabled/disabled by the
simultaneous actuation of both ON/OFF button 32 and
memory .button 50 as the instrument 10 is turned on.

30 The instrument 10 denotes errors by displaying

the "X" icon in combination with an error message or
other icon. There are two error types: recoverable and
non-recoverable. Strip errors are correctable by removal
of the strip 106 from the instrument 10. All other

35 errors are non-recoyerable and require the instrument 10

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to be turned off in order to clear the error.

The following errors are recoverable strip
errors. Removal of the strip will cause the instrument
10 to return to the dosed strip prompt: the Bad Strip
5 error, caused by an improperly reacted strip 106 or a
strip 106 which is degraded in any way as to make its
state indeterminable; and the Strip in Backwards error,
caused by the strip 106 being inserted with its blood
application side toward the instrument 10 »s optics.
10 The following errors are non-recoverable, as

they are the results of instrument measurement problems:
the Dirty Optics error, which occurs if the instrument
10 «s white tile 142 is dirty or degraded, or if the
instrument 10 is turned on with a strip 106 already

15 inserted in it; the Electronics Fault error, which is

caused by the detection of a fault during the instrument
10 »s power-on self -test or during a diagnostic check; the
Strip Removed During Test error, which is caused by
removing a strip 106 during the performance of a test so

20 that instrument 10 is unable to complete the test cycle;
and, the Coding error, which is caused by the detection
of a code ROM key 64 read error or a mismatch of the lot
code number read when instrument 10 is turned on with the
lot code number read just prior to the calculation of a

25 glucose result. The only remedy for these errors is to
turn the instrument 10 off.

The instrument 10 provides certain prompt
messages to the user, including: the Strip Removal
prompt, by which the instrument prompts the user to

30 remove a strip 106 by displaying the strip icon and left
arrow (<) icon; and the Dosed Strip prompt, by which the
instrument 10 prompts the user to insert a dosed strip
106 by displaying the strip icon, right arrow (>) icon,
and flashing the blood drop icon. Flashing segments or

35 icons in any mode of operation are displayed for 0.5

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second and off for 0.5 second.

In addition to its normal operating mode for
determining the remissions of reacted test strips , the
instrument 10 has a diagnostic software package that is
5 accessed via installation of a special diagnostic ROM

code key 64. The diagnostic ROM code key 64 is installed
in key housing portion IB before the instrument 10 is
turned on. Once the instrument 10 is turned on with the
diagnostic ROM code key installed, the following
10 functions are accessible instead of the normal operating
modes.

Once instrument 10 is turned on in the
diagnostic mode, instrument 10 enters the check strip
diagnostic. The instrument displays dl in the glucose

15 value field, or results field, for one second. After one
second the instrument 10 additionally displays the strip
icon and right arrow. icon to prompt the operator to
insert a check strip 106 provided with the diagnostic
code ROM key 64. If the user presses memory button 50

20 during this display, the instrument 10 advances to the
next diagnostic test.

Upon insertion of the check strip, the
instrument 10 measures the remission of the check strip
and compares this remission to a target remission value;

25 range stored in the diagnostic code ROM key 64. If the
measured remission agrees with the target value range
then the results field of the display 76 is blank,
transducer 80 beeps once and the user is then prompted to
remove the check strip by turning off the right arrow

30 icon, and turning on the left arrow icon while continuing
to display the strip icon.

Upon removal of the check strip from the
instrument 10 after a successful check, the instrument 10
returns to the start of the check strip diagnostic

35 routine and remains in this routine until the instrument

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10 is turned off, or until the user advances to the next
diagnostic routine by pressing the memory button 50.

If the measured remission of the check strip
does not match the target value in the diagnostic code
5 ROM key 64, the instrument 10 beeps three times, CLE

flashes in the results field on display 76, and the error
icon "X" is displayed. The only way to exit this display
is to turn instrument 10 off.

If the user advances past the first diagnostic

10 check by pressing memory button 50, then the IR

(infrared) sensor check is prompted by displaying d2 in
the results field. After one second, the instrument 10
checks for the presence of a strip in the instrument by
using the reagent pad detector . If the instrument 10

15 determines that a strip 106 is in the instrument 10, it
prompts the user to remove the strip by displaying the
strip icon and left arrow icon until the strip is
removed.

if the instrument 10 detects no strip, the
instrument 10 then reads the IR detector 266. If the IR
detector 266 reads a remission value inconsistent with an
empty strip carrier 120, 134, then instrument 10 displays
OFF in the results field of display 76 to signify that
the IR detector 266 is sensing a strip 106 when none is
25 present. This display will remain until the instrument

10 is turned off. »

If the instrument 10 determines that no strip
106 is present and that the IR detector 266 sees no strip
106, then it prompts the user to insert a strip 106 by

30 displaying the strip icon and right arrow icon until a
strip 106 is detected by the reagent pad detector 300.
Once a strip 106 is sensed by the reagent pad detector
300, the strip detector 266 is measured. If this
measurement is inconsistent with the presence of a strip

35 106 in the instrument 10, then the instrument 10 beeps

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three times, the display field displays OFF and the error
X icon flashing until instrument 10 is turned off.

If the IR detector 266 senses the presence of a
strip 106 in the instrument 10 , then the results field of
5 display 76 is blank, and the user is prompted to remove
the strip 106 by displaying of the strip icon and left
arrow icon. Once the strip 106 is removed, the display
76 returns to the d2 display until the user advances to
the next diagnostic check by pressing memory button 50 or
10 until instrument 10 is turned off.

If the user advances past the customer control
strip diagnostic and past the IR sensor 266 check by
using memory button 50, then the display check will be
prompted by displaying d3 in the results fifeld for one
15 second. After one second, all segments of the display 76
will be displayed for five seconds. Display 76 then
alternates between the d3 display and the all segments
display until the user advances to the next diagnostic ,
check by pressing memory button 50 or until instrument 10
20 is turned off.

Jf the user advances past the first three
diagnostic checks by using memory button 50, then the d4
prompt for the transducer 80 check will be displayed in
the results field. After one second, transducer 80 beeps
25 for two seconds regardless of whether the user has

transducer 80 switched off or not. After transducer 80
has beeped for two seconds, it will turn off for one
second and then on for two seconds and so on, until the
user advances to the next diagnostic check by pressing
30 memory button 50 or until the instrument 10 is turned
off.

If the user advances past the first four
diagnostic checks using memory button 50, then instrument
10 enters the battery check and prompts the user by
35 displaying d5 in the results field, and displaying the

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battery icon. At the end of one second, the instrument
10 repeats its power-on battery check.

The instrument 10 displays a number based on
the following calculation:
5 present f^+tTV voltage X 100

battery low warning voltage
Of course, numbers of less than 100 are displayed if the
battery icon was being displayed prior to entering the d5
diagnostic.

10 This display will remain on until the user

returns to the first diagnostic check, dl, by pressing
memory button 50 or until instrument 10 is turned off.

The operation of certain software functions of
the disclosed instrument may be better understood by

15 reference to the attached source listing for 200 and
illustrative data stored in the EEPR0M of a typical key
64. in the source listing, CRD or Chemistry Remission
Difference is the amount of remission difference which a
delta must be less than in order to reach the end of

20 reaction (EOR) . CRD is a 12 bit number in bank 1 RAM
which is an input to the function REACTION. The format
of CRD is a 12 bit binary remission multiplied by forty.

IWMI is an 8 bit number in bank 1 RAM which is
an input to function REACTION which determines the number

25 of half second increments of time to delay before taking
the first remission. IWMI is allowed to be from 0 to
255. If IWMI equals 0, then no delay will occur. If it
equals 1 then one half second of delay will occur, and so

on.

TINC is an 8 bit number in bank 1 RAM. TINC is
an input to the function REACTION which determines the
number of half second increments of time which will
elapse between successive remission readings. TINC is
permitted to be from 0 to 255. If it is 0, then one •
35 half-second increment of time will elapse. If it is 1,
then two half-second increments will elapse, and so on.

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NPS is an input to the function REACTION which
is a 4 bit number in bank 1 RAH. NPS represents the
number of remission readings that will be taken between
comparisons. It is allowed to be from 1 to 6. If NPS=1,
5 then one remission reading is taken between those which
are compared , and so on.

NPSA is an 8 bit number in bank 1 RAN which is
an input to function REACTION. NPSA is a function of
NPS. NPSA essentially contains the same information as
10 NPS but in a form which is more easily used by the
processor. It is defined as:

NPSA - (NPS+1) * 8
IWMA is an 8 bit bank 1 RAH number. IWHA is an
input to function REACTION. IWHA controls the number of
15 comparisons that the EOR portion of the algorithm will
make before it terminates. IWHA is permitted to be from
1 to 255. If IWHA equals i, then only one comparison
will be made. If IWHA equals 2, then a maximum of two
will be made , and so on.
20 ers is a 1 bit number in bank l RAM which is an

input to function REACTION. ERS causes the HAX_F flag to
be set if the function REACTION reaches EOR by reaching
IWHA.

EORREM 1 is a 32 bit floating point number in
25 bank l RAH which contains the last remission taken by
function REACTION. EORREM 1 is an output of function
REACTION.

E0RC0UNT is an 8 bit bank 1 RAH number which
contains the number of comparisons done during EOR. It
30 will never equal 0. It will always be from 1 to 255.
E0RC0UNT is an output of function REACTION.

HAX_F is an output of function REACTION. HAX_F
is a 1 bit bank 1 RAH number. HAX_F is set equal to 1 if
EOR is reached by the number of comparisons equalling
35 IWHA and ERS is also 1. If these conditions are not met ,

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then MAX^F is cleared to zero.

TRACE_F is a 1 bit bank 0 (zero) RAM input to
module REACTION which indicates that the meter is in
TRACE MODE. In TRACE MODE, all remission readings are
5 sent out the I/O port.

SE_F is a 1 bit bank 1 RAM number which is an
output. If SE_F is set, a strip error has occurred. Two
conditions can cause this: (1) EORREM i less than COL or
greater than COH; or (2) EOR reached by finding a delta
10 less than CRD, but the last 2 remissions taken did not
have deltas less than CRD.

COL is a bank 1 RAM location. Its format is a
12 bit binary remission multiplied by 40. All EORREM 1
values found by this function are compared to this
15 number. If EORREM 1 is less than COL, then SE_F is set.

COH is a bank 1 RAM location. The format is a
12 bit binary remission times 40. All EORREM 1 values
found by this function are compared to this number. If •
EORREM 1 is greater than COH, then SE_F is set.

PBACTION A SSESSMENT

Rinrnnary

Reaction Assessment is responsible for
25 observing the strip adaptor and determining when the

remission of the object in the strip adapter has reached
the EOR. It does this by periodically taking full power
chemistry pad remissions and analyzing these against
parameters found in the external ROM. The final
30 remission is placed in a reserved location in RAM. In
addition, Reaction Assessment determines how many
comparisons were made during the search for EOR. During
the operation of this module, a rotating arrowhead is
displayed on the LCD display as a means of indicating
35 that this module is operating. This module also

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transmits the value of each remission taken out the
serial port if TRACE_F is set. If the MEM button is
pushed during the execution of this module, then control
passes to the STRIP INTEGRITY module and Reaction
5 Assessment is aborted.

More pet?iiefl ExpiHaneUpyi

This function is responsible for observing the
strip adapter and determining when EOR occurs or if the

10 MEM button is pushed. In addition, Reaction Assessment
displays a rotating arrow on the LCD as a means of
providing a visual indication that the meter is busy. It
also outputs each remission taken if TRACE_F is set.

Reaction Assessment begins by clearing the LCD

15 and darkening a single arrowhead. The first arrowhead
darkened is not specif ied and will vary indeterminately.
For the duration of the execution of this function the
LCD will change its display every half second. The
display will change by lightening the arrowhead that is

20 currently dark and darkening the arrowhead which is
adjacent to it in the clockwise direction. At the
completion of ; this function the duration of time since
the LCD display was changed will be between approximately
20 and 300 msec. A typical time will be around 100 msec.

25 This duration varies with the time required to take a
remission and whether TRACE_F is set or not. It is
intended that if a continuation of the rotating arrowhead
display is desired following the completion of this
function, then it is necessary to wait another half

30 second before changing the LCD display. In addition/ SE
F is cleared at this time.

Reaction Assessment employs the power
conservation module so that when it is not actively
taking remission readings or doing calculations it puts

35 the meter in a power conservation mode which minimizes

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power consumption yet still permits the meter to respond
immediately to any event which can cause a termination of
power savings.

The second thing that this function does is to
5 examine RAM location IWMI to determine the amount of

initial delay before taking the first remission reading.
IWMI is an 8 bit binary integer . Each count of IWMI
represents a half second of delay. IWMI may be from 0 to
255. 0 implies no delay and 255 implies 255 half seconds

10 of delay. An example of IWMI is illustrated in Pig. 11.
Here, IWMI has a value of 3. This causes 1.5 seconds of
delay from the start of this function to where the first
remission is taken. ,

Once the requirements of IWMI have been met,

15 then a Single, full power remission is taken on the

chemistry channel. This remission is referred to as the
first remission reading.

The next task that the function REACTION
performs is a TRACE CHECK. This involves checking the 1

20 bit RAM location TRACE_F. If this location holds a 0,
nothing happens, if it holds a 1, then the remission
just taken is sent out the serial port as a 4 byte
floating point number (least significant byte first) in
the PC communication format. >■

25 The EOR portion of this function is conducted

at this time. To reach EOR, one of two events must
occur. Either a comparison of two remissions is found to
have a change, or delta, which is less than CRD, or a
time-out occurs after a number of comparisons equal to

30 IWMA has been made.

Bnd of Reaction fay a chieving a DELTA < CRD

Crd is a number found in RAM which is a limit
for how small delta must be in order to constitute EOR.

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Delta is the result of subtracting the most recent
remission from a prior remission determined by ROM code
key 64 parameter NPS. The comparison between CRD and a
delta is. made as follows:
5 * s I delta I < I CRD I ?

If the answer to this question is yes, then EOR has been
reached. If not, then another comparison must be made.

The timing for these events can best be
described in connection with Fig. 11. The first

10 remission reading has already been taken (time = 1.5

sec). The amount of delay until a subsequent remission
reading is taken is controlled by TINC. If TINC equals
0, then the delay increment will be one half second. If
TINC equals l, then 2 increments of one half second will

15 occur. TINC is permitted to vary from 0 to 255, so it
will provide delays of from .5 to 128 seconds. The
example in Fig. 11 shows a TINC of 1 which causes a delay
of two one half second increments between remission
readings.

20 A delta is formed by comparing two remission

readings. The two remissions compared are determined by
RAM locations NPS and NPSA. NPSA « (NPS+1)*8. NPS
refers to how many previous remissions will be skipped
before using a remission to form a delta. If NPS equals

25 1, as in the example of Fig. 11, then one remission is

skipped. For this example, tie first delta is calculated
after the third remission reading is taken. Hie delta is
calculated by subtracting the first remission reading
from the third remission reading. NPS is permitted to be

30 fjrom 0 to 6, permitting from 0 to 6 remission reading to
be skipped between comparisons. If, for example, NPS*6,
six remission readings are skipped, and the remission
reading which was detected seven remission readings ago
is the one that is used to calculate delta.

35 ram location EORCOUNT is used to keep track of

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how many comparisons are made during this function. At
the beginning of this function, EORCODNT is set equal to
zero. RAM location EORCODNT is incremented by 1 each
time a comparison is made until a delta less than CRD is
5 found. If a delta is found that is less than CRD, then
the software decides that EOR has been reached. In the
example provided in Fig. 11, a delta less than CRD was
reached when the fourth reading was taken. Therefore,
the final EORCODNT value for this example is 2.

10 once the EOR is reached by finding a delta less

than CRD, one more remission reading is taken after a
time interval controlled by TINC. Following this
remission, a Trace Check remission is read. This Trace
Check remission is also compared to a previous remission

15 controlled by NPSA. EORCODNT is not incremented when
this remission is read and its corresponding delta is
calculated. If this delta is less than CRD, then the
remission just taken will be stored at RAM location
EORREM1. The software will then continue as described

20 following the next paragraph. If this delta is not less
than CRD, then the meter will continue as described in
the next paragraph. Fig. 11 does not illustrate this
condition since the fifth reading is quite low and the
delta (THIRD DELTA) created thereby is greater than CRD.

25 However, if THIRD DELTA had beesi less than CRD, then the
fifth reading would have been the last and would
illustrate this condition.

The meter next takes another remission reading
immediately without waiting for TINC. This remission is

30 compared to the same remission as is the remission taken
after delta less than CRD. The example in Fig. 11 shows
a delta being created between the third reading and the
sixth reading. If the delta is not less than CRD, then
the 1 bit RAM location SE_F is set. EORCODNT is not

35 incremented when this remission is read and its

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corresponding delta is calculated. This remission is
stored at RAM location E0RREM1 . A Trace Check is
performed. The function now proceeds as described below.
Each time a comparison is made, the RAM
5 location EORCOUNT is incremented by 1. EORCODNT is
zeroed at the beginning of this function. If so many
comparisons are made that EORCOUNT equals IWMA, then EOR
will have been reached. If this happens, and if the 4
bit RAM location ERS equals 1, then the 1 bit RAM

10 location MAX_F is set. Otherwise MAX_F is cleared by
this function, regardless of how this function
terminates. An example of this type of EOR is given in
Fig. 12. Here, IWMA equals 5. After five comparisons
(deltas) are calculated and none of these deltas are

15 found to be less than CRD, EOR is reached.

Once EOR has been found by reaching IWMA, then
another remission is taken after TINC has elapsed.
Following this remission, a Trace Check remission is read
immediately. This remission is then written into RAM

20 location EORREM1.

Regardless of how EOR was reached, this
function now proceeds by outputing 4 bytes of EEH if the
TRACE_F is set. This indicates to a PC that the function
REACTION is completed.

25 The last thing REACTION does is to check if the

EORREM1 value is greater than RAM number COL and less
than RAM number COH. If EORREM1 is not between COL and
COH then the S^_F bit in RAM is set. If E0RREM1 is
between COL and COH then the SE_F bit is not modified. It

30 is possible that EOR was reached by finding a delta less
than CRD, and that the last two remissions did not meet
the CRD requirements but the last remission was within
the limits set by COL and COH. In this case, a strip
error is still considered to have occurred, and the SE^F

35 bit remains set.

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Throughout this entire function, the meter is
alert for a pressing of the MEM button. If the MEM
button is pressed, then a branch to the STRIP INTEGRITY
function is performed. This terminates the Reaction
5 Assessment function.

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Claims:

1. A device for accepting a strip, the strip
supporting a chemistry the remission of which changes as
5 the chemistry reacts with a medically significant

component of a body fluid to indicate the concentration
of the component in the body fluid, the strip having
opposed major surfaces, the device comprising a pathway
along which radiation is guided from a radiation source

10 to the chemistry when the strip is properly inserted into
the device and along which remission is guided from the
chemistry to a radiation detector when the strip is
properly inserted into the device, a tile for providing a
standard remission, means for movably supporting the tile

15 to permit it to move from a position in which it receives
radiation from the radiation source and produces the
standard remission which is guided along the pathway to
the radiation detector when no strip is inserted into the
device to a position separated from the radiation source

20 by the strip when the strip is inserted into the device,
the means for movably supporting the tile comprising a
strip carrier including a carrier body having a surface
facing the tile, a lift for movable engagement by the
carrier, one of the carrier and lift providing a pair of

25 elongated slots the long dimensions of which extend

generally transversely to the directions of motion of the
strip into and from the device and generally transversely
to the major surfaces of the strip when the ptrip is
inserted into the device, the other of the carrier and
30 lift having a pair of oppositely extending trunnions for
engaging the slots, the lift further including incline
means for engagement by the strip as the strip is
inserted into the device to move the lift away from the
carrier as permitted by the engagement of the trunnions
35 in the slots and permit insertion of the strip between

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the carrier and lift, the inpline means provided at an
entry end of the carrier and lift, means for yieldably
urging the lift toward the facing surface of the carrier
so that the lift lies against the facing surface of the
5 carrier when no strip is inserted into the device.

2. The device of claim 1 wherein one of the
lift and tile further includes a pair of opposed, aligned
holes extending generally transversely to the directions
of motion of the strip into and from the device, the axes

10 of the holes extending generally parallel to the major

surfaces of the strip when the strip is inserted into the
device, the other of the lift and tile including a pair
of oppositely extending second trunnions for engaging the
holes to mount the tile pivotally from the lift.

15 3 . The device of claim 1 wherein the facing

surface and the tile are so shaped that the tile surface
Is maintained at a distance from the facing surface of
the carrier when no strip is inserted into the device and
at a distance from the strip when a strip is inserted

20 into the device.

4 . The device of claim 1 and further
comprising a housing for positioning the assembly
including the strip carrier, the lift and the tile, the
housing including a second surface remote from, and

25 generally parallel to, the facing surface when the

assembly including the carrier, the lift and the tile is
positioned in the housing, the lift and tile lying
between the facing surf ace and second surface, the means
for yieldably urging the lift toward the facing surface

30 comprises a compression spring, and the spring bears

against the second surf ace and at least one of the lift

and the tile.

5. The device of claim 1 wherein the housing
further comprises means for supporting the radiation

35 source, the pathway along which radiation is guided from

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the source to the chemistry when the strip is properly
inserted into the device including a first slot formed in
the facing surface opposite the tile when no strip is
inserted into the device and opposite the chemistry when
5 a strip is properly inserted into the device, the first
slot being located adjacent the means for supporting the
radiation source for directing radiation therefrom onto
the tile when no strip is inserted into the device and
onto the chemistry when a strip is properly inserted into

10 the device.

6. The device of claim 5 wherein the pathway
along which remission is guided from the chemistry to the
radiation detector when a strip is properly inserted into
the device also includes the first slot.

15 7. The device of claim 6 wherein the housing

includes a third surface which lies adjacent the facing
surface when the assembly including the carrier , the lift
and the tile is inserted into the housing, the third
surface lying adjacent the carrier body and extending

20 generally parallel to the facing surface, the pathway

along which remission is guided from the chemistry to the
detector when a strip is properly inserted into the
device including a second slot formed in the third
surface adjacent the first slot.

25 8. The device of claim 7 wherein the housing

includes a fourth surface lying at a small, nonzero angle
to the third surface, the pathway along which radiation
is guided from the source to the chemistry when the strip
is properly inserted into the device including a third

30 slot formed in the fourth surface.

9. The device of claim 8 wherein the third
slot lies between the source and the chemistry when the
strip is properly inserted into the device.

10. The device of claim 9 wherein the first
35 slot lies between the third slot and the chemistry when

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the strip is properly inserted into the device.

11. The device of claim 10 wherein the first
slot lies between the chemistry and the detector when the
strip is properly inserted into the device.
5 12. The device of claim 11 wherein the second

slot lies between the first slot and the detector.

13. The device of claim 8 wherein the fourth
surface lies between the means for supporting the
radiation source and the chemistry when the strip is

10 properly inserted into the device.

14. The device of claim 5 wherein the housing
further includes a second surface which lies adjacent the
facing surface when the assembly including the carrier,
lift and tile is inserted into the housing, the second

15 surface lying adjacent the carrier body and extending
generally parallel to the facing surface, and a second
pathway along which radiation is guided from a second
radiation source to the strip when the strip is inserted
into the device and along which remission is guided from

20 the strip to a second radiation detector when the strip
is inserted into the device.

15. The device of claim 14 incorporated into
an instrument for determining the concentration of a
medically significant component of a body fluid and for

25 indicating the determined concentration of the medically
significant component to a user of the instrument, the
instrument comprising an instrument case for the
instrument's components including the device, one of the
instrument's components comprising a printed circuit

30 board, the housing, the first-mentioned and second

radiation sources, and the first-mentioned and second
radiation detectors being mounted on the printed circuit
board.

16. The device of claim 4 wherein the housing
35 includes a third surface lying adjacent, and extending

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generally parallel to, the carrier body/ one of the third
surface and carrier body being provided with a locating
protrusion and the other of the third surface and carrier
body being provided with a recess for receiving the
5 protrusion to locate the carrier, lift and tile correctly
within the housing when the holder with the carrier, lift
and tile assembled and supported thereon is assembled to
the case by sliding insertion of the carrier, lift and
tile assembly into the housing*
10 17 . The device of claim 16 wherein the

protrusion and the relief are generally frustoconical.

18 . The device of claim 17 wherein the
protrusion is provided on the third surface.

19. The device of claim 1 incorporated into an
15 instrument for determining * the concentration of a

medically significant component of a body fluid and for
indicating the determined concentration of the medically
significant component to a user of the instrument, the
instrument comprising an instrument case for the

20 instrument's components including the housing, the lift,
the tile and the carrier, the case including a removable
case portion having an exterior surface and an interior
surface, the exterior surface lying on the outside of the
case when the case portion is in its use orientation on

25 the instrument, and the interior surface lying on the
inside of the case when the case portion is in its use
orientation on the instrument, one of the interior
surface and the strip carrier provided with a pair of
generally pawl-shaped members which extend away from the

30 interior surface and define between them a slot which
opens into a somewhat triangular region near their ends
remote from the interior surface, then closes back to its
slot configuration, the other of the interior surface and
the strip carrier including a web portion having opposite

35 sides from each of which project two, generally parallel

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guide ribs and, between the guide ribs of each pair, a
projection for engaging the triangular region defined
between the remote ends of the pawl-shaped members when
the web portion is inserted into the slot.
5 20. The device of claim 1 incorporated into an

instrument for determining the concentration of a
medically significant component of a body fluid and for
indicating the determined concentration of the medically
significant component to a user of the instrument.

10 21. The instrument of claim 20 comprising an

instrument case for the instrument^ components including
the device, the. case defining an instrument exterior, the
case including a holder for supporting the carrier, lift
and tile assembly and for aligning and orienting the

15 carrier, lift and tile assembly for longitudinal sliding
insertion into, and removal from, the housing, the
carrier including a web region extending longitudinally
of the directions of motion of the carrier, lift and tile
assembly into and from the housing, a pawl provided oh

20 the web region, the pawl having a locking surface on the
side thereof which projects first into the instrument and
an inclined camming surface on the side thereof which
retracts first out of the instrument, the holder
including a pair or resilient f ingers between which the

25 wet> is slidably received, one of the fingers including a
pawl receiving portion having an inclined face and a
locking face, the pawl engaging in the pawl receiving
portion with the locking surface of the pawl engaging the
locking face of €he pawl receiving portion and the

30 inclined surface of the pawl engaging the inclined face
of the pawl receiving portion.

22. A device for accepting a strip, the strip
supporting a chemistry which reacts with a medically
significant component of a body fluid to indicate the

35 concentration of the component in the body fluid, the

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device comprising a pathway along which radiation is
guided from a radiation source to the strip when the
strip is inserted into the device and along which
remission is guided from the strip to a radiation
5 detector when the strip is inserted into the device, a
housing for providing a first remission, the housing
receiving radiation from the radiation source and
producing the first remission which is guided along the
pathway to the radiation detector when no strip is

10 inserted into the device, the housing separated from the
radiation source by the strip when the strip is inserted
into the device, the first remission and the strip's
remission respectively indicating the absence and the
presence of the strip in the device.

15 23. The apparatus of claim 22 wherein the strip has

opposed major surfaces, the strip 1 s remission being the
remission of a first of the major surfaces, the second of
said major surfaces characterized by a second strip
remission different from the first strip remission, the

20 radiation detector producing a first output in response
to detection of the first strip remission and a second
and different output in response to the second strip
remission.

,24. The apparatus of claim 23 wherein the device
25 further comprises a second radiation source, a second
radiation detector, and a second pathway along which
radiation is guided from the second source to the
chemistry when the strip is properly inserted into the
device and along which remission is guided from the strip
30 to the second radiation detector when the strip is

properly inserted into the device, the second radiation
detector producing different outputs based upon
differences in remission of the chemistry corresponding
to different concentrations of the medically significant
35 component in the body fluid.

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160

FIG. 3

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FIG. 2

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8/12

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^ — to* JO Jg> Xro

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% REMISSION

i i

11/12

FIRST DELTA '

NPS»l,NPSA» 16^

1st
READING |

SECOND DELTA -
NPS*i,NPSA=l6

THIRD DELTA _
f*~~NPS»i, N PSA* 16

, 2nd
READING

I 3rd
| READING |

4th
READING

r F D°E U LTaM 6 th
1 0ELTA I READING

-1WM1» 3- — »-U-TINC»lrvl-ii-TINC»i-*-U-TINC»i

-r

— r—

1.0

1.5

— i —

2.0

REACTION
ASSESSMENT
BEGINS HERE

"Ji 30 3.5 AO 4.5 5.0 55
TIME (HALF SECOND INCREMENTS) /

EOR IS
FINISHED
HERE

EOR BEGINS
HERE

IWMA>2
ERS - I OR 0
EOR COUNT 8 2
MAX_F»0

TOTAL NUMBER OF REMISSIONS TAKEN »5
EOR REM 1 RECEIVES THE 5TH READING

FIG. H

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% REMISSION

4th
DELTA

2.0 2.5 3.0 3.5 40 4.5 5.0
TIME (HALF SECOND INCREMENTS)

5th
DELTA

FINAL
REMISSION

r
5.5

REACTION ASSESSMENT
AND EOR BEGIN HERE.

SJO

EOR IS FINISHED
HERE

IWMA»5
ERS-i

E0RC0UNT»5
MAX.F* i

TOTAL NUMBER OF REMISSIONS TAKEN
E0R.REM1 RECEIVES THE 13th READING

TINC'O
IWMI*0
NPS »6
NPSA«5S

M 12

INTERNATIONAL SEARCH REPORT

International Application No. PCT/US92/01734

I. CLASSIFICATION OF SUBJECT MATTER (If several classification symbols apply, indicate all) 3

According to International Patent Classification (IPC) or to both National Classification and IPC
IPC (5) r G01H 21/01, 21/75

US CL : 422/58, 68.1, 82.05? 436/164, 165

IT. FIELDS SEARCHED

Minimum Documentation Searched 4

gaaaffication System

Claeaifloation Symbole

U.S.

422/58, 68.1, 82.05; 436/164, 165

Documentation Searched other than Minimum Documentation fi
to the extent that suoh Documents are included In the Raids Searched

APS search terms: OMRON, BIOCHEMICAL, REFLECTION LIGHT EMITTING, METER,
TEST STRIP, DENSIMETER, GLUCOSE

III. DOCUMENTS CONSIDERED TO BE RELEVANT

Category]

Citation of Document, 1 * with Irrigation, where appropriate, of the relevant passages* 7

Relevant to Claim No. 1 •

X/Y

y,p
y,p

A
A
A

A,P
A,P

US, A, 4,509,859 (Markart et al.) 09 April 1985. See
entire document.

US, A, 4,676,653 (Strohmeier et al.) 30 June 1987. See
entire document.

US, A, 5,037,614 {Makita et al.) 06 August 1991. See
entire document.

US, A, 5,039,615 (Takahata) 13 August 1991. See figure
1 and the associated discussion.

JP, A, 63-269046 (Makita et al.) 07 November 1988. See
entire document.

US, A, 4,871,258 (Herpichboehra et al.) 03 October 1989.
See entire document.

US, A, 4,934,817 (Gassenhuber) 19 June 1990. See
entire document.

US, A, 5,035,199 (Reiser et al.) 01 October 1991. See
entire document.

US, A, 5,059,394 (Phillips et al.) 22 October 1991.
See entire document.

22,23/24

14,15,24

1-21

1-24

•r later document publiehad after the international filing
data or priority data and not in conflict with the
application but cited to understand the principle of
theory underlying the Invention

"X* document of particular relevance; the claimed
invention cannot be considered novel or cannot be
considered to involve an inventive stsp

nr document of particular relevance; the claimed
. invention cannot be considered to involve an
inventive ttep whan the document i« combined with
' one or more other such documanta, auch combination
being obvious to a person skilled In the art

•V document rnember of the same patent famOv

* Special categories of oitad documents:^

•A" docurnsnt drfcinq the gensral etste of the art which »

not ooneidered to be of particular reievanca
T earfcer document but pubeshad on or after the

International ling data ■
f document whtoh may throw doubts on priority daimW

or which is oitad to establish the pubecetion data of

another citation or other special reason (as specified)

*0" documem referring to art or^

•P- document pubfehed prior to the Irterwttoriai fiang data
but later then tr^ Priority data claimed

IV. CERTIFICATION

Date of the Actual Completion of the
19 MAY 1992

tntemeuonsi ossren

Data of Mailing of this International Search Report 2

10 JUN1992

International Searching Authority *
ISA/US

Signature of Authorized Officer
ARLEH SODERQOIST

Form PCTAS A/210 (second ehsetHMey 1986) ft

International Application No, PCT/US92/01734

FURTHER INFORMATION CONTINUED FROM THE SECOND SHEET

Diabetes, Vol. 33, Supplement 1, issued May 1984, D.
Michaels et al., "A MEMORY- GLUCOSE REFLECTANCE METER
FOR AUTOMATIC DATA RECORDING 1 ?, entry 498, pg. 130A.
See entire document.

Diabetes, Vol. 33, Supplement 1, issued May 1984, J.
Silverstein et al., "COMPARISON OF SYSTEMS FOR BLOOD
GLUCOSE MONITORING WITH A METER: ACCU-CHEK® AND
GLUCOMETER*" , entry 502 pg. 131A. See entire entry.

Diabetes, Vol. 33, Supplement 1, issued May 1984, D.
Hiennen et al., "ASSESSMENT OF ACCURACY OF 11 GLUCOSE
MACHINES FOR HOME USE", entry 503 pg. 131A. See entire
entry.

1-24

V»D OBSERVATIONS WHERE CERTAIN CLAIMS WERE FOUND UNSEARCHABLE 1

1.Q CUkn numbara bacauaa thay ralata to aubjact matter (1) not nquind to be «««rch«J by tNt Authority, nmr^r.

2. □ Claim numbara bacauaa thay ralata to partaof thelrtomatfonal
preecribed re**ernenta to audi an axtent that no maaningM ^

application that do not comply with tha
aaarch can ba carried out(1>.

3.Q CUaw nurnbere _,beeeuee thay aradapandant
of PCT Aie 6V4{a).

dafene not draftad In accocdanoa with tha aaoond and third eentencee

VI. □ OBSERVATIONS WHERE UNITY OF INVENTION IS LACKING*

Tbte International Searching Authority found muttipte inventione in tNe international appecation aa

1. n Aa al required addKSoneJ aaarch free wan) timalypaidbythaappacan^tKa
" daanal^lntamattonaiappBcafjOfV

2. □ Aaonly aoirw of tha «o^ adoltl^^

ontythoeedaifmc*their**matfon^

3.n No required «M*k>nel aaarch faaa

V tNa IntamaUonjI aaarch raport la

4. □ Aa al aaarchaWa deime cotttbeeearchei
LJ notlrwttapaym^crfanyadddfonaltoa.

without effort |uetify*io en edol^

Q Tha additional aaarch faaa w<
□ No protaat accornpaniad tha

era accornpaniad by appacant'a
paymant of additional aaarch faaa.

Form PCT/IS A/210 (eapplementeJ eheatOJHRav. 4-90) B

International Application No. PCT/US92/01734

W. DOCUMENTS CONSIDERED TO BE RELEVANT (CONTINUED FROM THE SECOND SHEET)

Category* Citation of Document, 10 with Indication, when) appropriate, of the relevant pwMQtt 17 Relevant to Qam No. 18

Diabetes, Vol. 33/ Supplement 1, issued May 1984, "V.G
Kuykendall et al., " INFORMATION MANAGEMENT FOR
GLUCOMBTER* REFLECTANCE PHOTOMETER WITH MEMORY" , entry

507, pg. 132A. See entire entry.

1-24

Form PCT/IS A/210 (extra eheetHMay 1980) a

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